Phase I/Randomized Phase II Study of Second Line Therapy With Irinotecan + Cetuximab +/- RAD001 for Colorectal Cancer
NCT00522665
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- Histological or cytological proof of colon or rectal adenocarcinoma
- Measurable site of disease according to RECIST that has not been previously irradiated
- Must have metastatic colorectal cancer which progressed after first line chemotherapy +/- bevacizumab
- Blood sample collected within 21 days prior to being registered for protocol therapy for UTG1A1 genotype analysis. (Patients with the UGT1A1 *28 7/7 genotype (homozygosity for the TA7 allele) will be excluded from the Phase I stage of the study. During the Phase II stage of the study, subjects will be allowed to participate but must begin treatment at dose level -1 of irinotecan.)
- A history of other malignancies (non-colorectal) is allowed, provided it has been curatively treated and demonstrates no evidence for recurrence of that cancer
- Prior radiation therapy allowed to < 25% of the bone marrow
- Age ≥ 18 years at the time of consent
- Written informed consent and HIPAA authorization for release of personal health information
- Females of childbearing potential and males must be willing to use an effective method of contraception
- Females of childbearing potential must have a negative pregnancy test within 7 days of being registered for protocol therapy
- No more than one prior chemotherapy regimen for metastatic colorectal cancer, at least
28 days prior to being registered for protocol therapy
- No prior treatment with cetuximab
- No prior treatment with an mTOR inhibitor
- No known hypersensitivity to cetuximab, RAD001 (everolimus), other rapamycins
(sirolimus, temsirolimus) or to its excipients
- No treatment with any investigational agent within 28 days prior to being registered
for protocol therapy
- No symptomatic brain metastasis
- No uncontrolled diabetes as defined by a fasting serum glucose >1.5 x ULN
- No chronic treatment with systemic steroids or another immuno-suppressive agent
- No serious non-healing wound, ulcer, bone fracture, major surgical procedure, open
biopsy or significant traumatic injury within 28 days prior to being registered for
protocol therapy
- No liver disease such as cirrhosis, chronic active hepatitis or chronic persistent
hepatitis
- No active bleeding or a pathological condition that is associated with a high risk of
bleeding
- No uncontrolled systemic disease including active infections or uncontrolled
hypertension
- No known history of HIV seropositivity
- No impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled
nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- No nonmalignant medical illnesses that are uncontrolled or whose control may be
jeopardized by the treatment with protocol therapy
- No planned immunization with attenuated live viruses during the study period
- Females must not be breastfeeding
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Descriptive Information | ||||
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Brief Title ICMJE | Phase I/Randomized Phase II Study of Second Line Therapy With Irinotecan + Cetuximab +/- RAD001 for Colorectal Cancer | |||
Official Title ICMJE | Phase I / Randomized Phase II Study of Second Line Therapy With Irinotecan and Cetuximab With or Without RAD001, an Oral mTOR Inhibitor for Patients With Metastatic Colorectal Cancer: Hoosier Oncology Group GI05-102 | |||
Brief Summary | The addition of RAD001, an mTOR inhibitor, to irinotecan and anti-EGFR antibody cetuximab may increase efficacy for patients with metastatic colorectal cancer who progressed on prior chemotherapy. This approach is biologically directed to overall target the cancer cell at multiple levels, and potentially preventing chemotherapy and EGFR-therapy resistance. | |||
Detailed Description | OUTLINE: This is a multi-center study. PHASE I:
PHASE II:
ARM A:
AT TIME OF PROGRESSIVE DISEASE, ARM A TREATMENT WILL CROSSOVER:
ARM B:
AT TIME OF PROGRESSIVE DISEASE, ARM B TREATMENT WILL BE DISCONTINUED ECOG performance status 0-2 Life Expectancy: Not specified Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Colorectal Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Chiorean EG, Picus J, Breen T, Ansari RH, Harb WA, Burns M, Spittler AJ, Loehrer PJ. Phase I/II study of everolimus (E) with irinotecan (Iri) and cetuximab (C) in 2nd line metastatic colorectal cancer (mCRC): Hoosier Cancer Research Network GI05-102. J Clin Oncol 33:5s, 2015 (suppl; abstr 3618) | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 41 | |||
Original Estimated Enrollment ICMJE | 110 | |||
Actual Study Completion Date ICMJE | February 2015 | |||
Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00522665 | |||
Other Study ID Numbers ICMJE | GI05-102 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Hoosier Cancer Research Network | |||
Study Sponsor ICMJE | Hoosier Cancer Research Network | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Hoosier Cancer Research Network | |||
Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |